BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 7028792 · Received November 14, 2017

    Report

    Report Number
    2246980-2017-00030
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COURSE OF THE PRODUCT INVESTIGATION, VISUAL AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PRODUCT. THE INVESTIGATION CONFIRMED THE CUSTOMER CLAIM AND A NONCONFORMANCE HAS BEEN OPENED TO GARNER FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "MASK AND SOME CONNECTORS ARE MISSHAPEN. THEY DO NOT FIT ONTO THE BAG OR SEAL CORRECTLY." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809136 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF1140MB 309778

    Patients

    Seq Age Sex Outcome Treatment
    1